The emergence of new diseases and infections has entailed the need for rapid and efficient development of safe and efficacious vaccines. Additionally, no effective vaccines currently exist for long-known pandemic diseases such as HIV or malaria. To address the challenges the vaccine industry faces, new vaccine modalities such as viral vectors, recombinant protein subunits, and nucleic acids are being researched and developed, with each vaccine production process being unique and having its own challenges and regulatory impediments.
The growing diversity of vaccines calls for development and manufacturing solutions tailored towards each vaccine molecule type. This is valid specifically for downstream processes as each molecule requires its own unique purification strategy. In conjunction, regulatory agencies expect safety and purity testing for a variety of analytes throughout the entire production process. Implementation and use of these assays are often time consuming and require significant resources and efforts.
During this webinar we present innovative chromatography solutions that can help in improving the downstream processes of different vaccine types. In addition, we will address regulatory requirements for safety and purity testing during the vaccine production process and discuss the benefits of implementing automated systems to save time and demonstrate product quality and safety.
Learning Objectives
- Understand the benefits of implementing affinity chromatography into a vaccine production process.
- Find out how Thermo Scientific POROS chromatography resins help to maximize efficiency of the downstream process of large molecules and vaccine modalities such as virus-like particles, viral vectors, proteins, and mRNA.
- Learn more on ways to confirm purity using industry-recognized and regulatory-accepted real-time PCR residual host cell DNA solutions, such as resDNASEQ.
- Understand mycoplasma testing regulatory requirements for lot release and how the MycoSEQ Rapid mycoplasma detection system has been validated and accepted by regulators in multiple modalities